id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
FDA-1995-D-0288-0051,FDA,FDA-1995-D-0288,"Ref. 7 - Q12 Technical and Regulatory Considerations for Pharmaceutical Producte Lyfecycle Managment Annex May 2021 RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry",Supporting & Related Material,Background Material,2021-07-07T04:00:00Z,2021,7,,,2021-07-07T12:23:19Z,,0,0,0900006484bd4b2d
FDA-1995-D-0288-0053,FDA,FDA-1995-D-0288,"Ref. 9 - Comparability Protocols for Human Drugs and Biologics April 2016 RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry",Supporting & Related Material,Background Material,2021-07-07T04:00:00Z,2021,7,,,2021-07-07T12:23:31Z,,0,0,0900006484bd4b2f
FDA-1995-D-0288-0054,FDA,FDA-1995-D-0288,"Ref. 15 - Good Review Managment Principles and Practice for New Drug Applications and Biologics License Sept 2018 RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry",Supporting & Related Material,Background Material,2021-07-07T04:00:00Z,2021,7,,,2021-07-07T12:23:37Z,,0,0,0900006484bd4b30
FDA-1995-D-0288-0052,FDA,FDA-1995-D-0288,"Ref. 7 - ICH Q 12 Annex RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry",Supporting & Related Material,Background Material,2021-07-07T04:00:00Z,2021,7,,,2021-07-07T12:23:25Z,,0,0,0900006484bd4b2e
FDA-1995-D-0288-0055,FDA,FDA-1995-D-0288,"Ref. 23 - Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research March 2019 RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry",Supporting & Related Material,Background Material,2021-07-07T04:00:00Z,2021,7,,,2021-07-07T12:23:44Z,,0,0,0900006484bd4b31
FDA-1995-D-0288-0050,FDA,FDA-1995-D-0288,"PAC FINAL GUIDANCE reference list RE Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry",Supporting & Related Material,Background Material,2021-07-07T04:00:00Z,2021,7,,,2021-07-07T12:23:11Z,,0,0,0900006484bcd0c7
FDA-1995-D-0288-0049,FDA,FDA-1995-D-0288,"Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry",Other,Guidance,2021-06-24T04:00:00Z,2021,6,2021-06-24T04:00:00Z,,2024-11-12T23:32:40Z,,1,0,0900006484baa9ff
FDA-1995-D-0288-0048,FDA,FDA-1995-D-0288,"Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Guidance for Industry; Availability",Notice,Notice of Availability,2021-06-24T04:00:00Z,2021,6,2021-06-24T04:00:00Z,,2021-06-24T14:02:39Z,2021-13392,0,0,0900006484ba948e
FDA-1995-D-0288-0030,FDA,FDA-1995-D-0288,"25 Reference 24 - ICH Harmonised Tripartite Guideline The Common Technical Document for the Registration of Pharmaceuticals for Human Use Quality re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2018-01-04T05:00:00Z,2018,1,,,2018-01-04T14:41:50Z,,0,0,0900006482d96265
FDA-1995-D-0288-0031,FDA,FDA-1995-D-0288,"26 Reference 25 - ICH Harmonised Tripartite Guideline Validation of Analytical Procedures Text and Methodology re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2018-01-04T05:00:00Z,2018,1,,,2018-01-04T14:41:58Z,,0,0,0900006482d962c0
FDA-1995-D-0288-0011,FDA,FDA-1995-D-0288,"08 Reference 7- Guidance for Industry Q10 Pharmaceutical Quality System re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:40:27Z,,0,0,0900006482d5898a
FDA-1995-D-0288-0016,FDA,FDA-1995-D-0288,"13 Reference 12 - Guidance for Industry On the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for Allergenic Extract re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:41:13Z,,0,0,0900006482d5898f
FDA-1995-D-0288-0006,FDA,FDA-1995-D-0288,"03 Reference 2 - Supplements and Other Changes to an Approved Application Final Rule re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:39:49Z,,0,0,0900006482d5894a
FDA-1995-D-0288-0022,FDA,FDA-1995-D-0288,"19 Reference 18 - Guidance for Industry Container Closure Systems for Packaging Human Drugs and Biologics re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:41:57Z,,0,0,0900006482d58999
FDA-1995-D-0288-0023,FDA,FDA-1995-D-0288,"20 Reference 19 - Q5D Quality of Biotechnological Biological Products Derivation and Characterization of Cell Substrates Used for Production of Biotechnological Biological Products re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:42:07Z,,0,0,0900006482d5899a
FDA-1995-D-0288-0026,FDA,FDA-1995-D-0288,"23 Reference 22 - Guidance Document Post-Notice of Compliance (NOC) Changes Quality Document - Canada_ca re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:42:29Z,,0,0,0900006482d5899d
FDA-1995-D-0288-0009,FDA,FDA-1995-D-0288,"06 Reference 5- Guidance for Industry Changes to An Approved Application for Specified Biotechnology and Specified Synthetic Biological Products re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:40:12Z,,0,0,0900006482d58988
FDA-1995-D-0288-0017,FDA,FDA-1995-D-0288,"14 Reference 13 - Guidance for Review Staff and Industry Good Review Management Principles and Practices for PDUFA Products re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:41:22Z,,0,0,0900006482d58990
FDA-1995-D-0288-0018,FDA,FDA-1995-D-0288,"15 Reference 14 - Draft Guidance for Industry Comparability Protocols for Human Drugs and Biologics Chemsitry Manufacturing and Controls Information re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:41:29Z,,0,0,0900006482d58995
FDA-1995-D-0288-0025,FDA,FDA-1995-D-0288,"22 Reference 21 - Guidance for Industry Qualtiy Systems Approach to Pharamceutical CGMP Regulations re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:42:22Z,,0,0,0900006482d5899c
FDA-1995-D-0288-0020,FDA,FDA-1995-D-0288,"17 Reference 16 - Guidance for Industry Q6B Specifications Tests Procedures and Acceptance Criteria for Biotechnological Biological Prodcuts re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:41:44Z,,0,0,0900006482d58997
FDA-1995-D-0288-0013,FDA,FDA-1995-D-0288,"10 Reference 9 - Guidance for Industry For the Submission of Chemistry Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products Animal re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:40:47Z,,0,0,0900006482d5898c
FDA-1995-D-0288-0012,FDA,FDA-1995-D-0288,"09 Reference 8 - Guidance for Industry Q11 Development and Manufacture of Drug Substances re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:40:39Z,,0,0,0900006482d5898b
FDA-1995-D-0288-0019,FDA,FDA-1995-D-0288,"16 Reference 15 - Draft Guidance for Industry Established Conditions Reportable CMC Changes for Approved Drug and Biologic Products re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:41:36Z,,0,0,0900006482d58996
FDA-1995-D-0288-0024,FDA,FDA-1995-D-0288,"21 Reference 20 -Guidance for Industry Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingrediants re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:42:15Z,,0,0,0900006482d5899b
FDA-1995-D-0288-0004,FDA,FDA-1995-D-0288,"01 List of References re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:39:35Z,,0,0,0900006482d58948
FDA-1995-D-0288-0002,FDA,FDA-1995-D-0288,"Chemistry, Manufacturing, and Controls Changes to an Approved
Application: Certain Biological Products; Draft Guidance for Industry;
Availability",Notice,Notice of Availability,2017-12-22T05:00:00Z,2017,12,2017-12-22T05:00:00Z,2018-03-23T03:59:59Z,2018-03-23T13:00:58Z,2017-27589,0,0,0900006482d56bc8
FDA-1995-D-0288-0021,FDA,FDA-1995-D-0288,"18 Reference 17 - Guidance for Industry Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:41:50Z,,0,0,0900006482d58998
FDA-1995-D-0288-0007,FDA,FDA-1995-D-0288,"04 Reference 3 - Quidance for Industry Q9 Quality Risk Management re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:39:57Z,,0,0,0900006482d5894b
FDA-1995-D-0288-0014,FDA,FDA-1995-D-0288,"11 Reference 10 - Guidance for Industry Content and Format of Chemistry Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:40:56Z,,0,0,0900006482d5898d
FDA-1995-D-0288-0015,FDA,FDA-1995-D-0288,"12 Reference 11 - Guidance for Industry Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:41:05Z,,0,0,0900006482d5898e
FDA-1995-D-0288-0028,FDA,FDA-1995-D-0288,"26 Reference 25 - ICH Harmonised Tripartite Guideline Validation of Analytical Procedures Text and Methodology re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:42:44Z,,0,0,0900006482d58788
FDA-1995-D-0288-0008,FDA,FDA-1995-D-0288,"05 Reference 4 - Guidance for Industry Changes to an Approved Application Biological Products Human Blood and Blood Components Intended for Transfusion or for Furthe Manufacture re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:40:05Z,,0,0,0900006482d5894c
FDA-1995-D-0288-0003,FDA,FDA-1995-D-0288,"Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Other,Guidance,2017-12-22T05:00:00Z,2017,12,2017-12-22T05:00:00Z,2018-03-23T03:59:59Z,2024-11-07T01:16:03Z,,1,0,0900006482d58944
FDA-1995-D-0288-0027,FDA,FDA-1995-D-0288,"25 Reference 24 - ICH Harmonised Tripartite Guideline The Common Technical Document for the Registration of Pharmaceuticals for Human Use Quality M4Q(R1) re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:42:35Z,,0,0,0900006482d58787
FDA-1995-D-0288-0005,FDA,FDA-1995-D-0288,"02 Reference 1 - Changes to an Approved Application Final Rule re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:39:41Z,,0,0,0900006482d58949
FDA-1995-D-0288-0010,FDA,FDA-1995-D-0288,"07 Reference 6 Guidance for Industry Labeling for Human Prescription Drug and Biological Products - Implementing the PLR Content and Format Requirements re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:40:20Z,,0,0,0900006482d58989
FDA-1995-D-0288-0029,FDA,FDA-1995-D-0288,"24 Reference 23 Quidance for Industry Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin re Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products Draft Guidance for Industry",Supporting & Related Material,Background Material,2017-12-22T05:00:00Z,2017,12,,,2017-12-22T16:42:53Z,,0,0,0900006482d5899e
FDA-1995-D-0288-0001,FDA,FDA-1995-D-0288,Guidance: Changes to be Reported for Product and Establishment License Application,Notice,Guidance,2017-07-28T04:00:00Z,2017,7,2017-07-28T04:00:00Z,,2017-07-28T20:17:33Z,,0,0,0900006480598d46